Protocol → Database Lock

Clinical Data,
End to End.

My work spans the clinical-data lifecycle: translating protocols into eCRFs, configuring and validating EDC systems, managing live-study data quality, reconciling external and safety data, and supporting controlled database lock.

11Phase I–III studies led
~11Medrio databases built
~10UAT cycles / databases
16Sites represented
Interactive lifecycle

Select a stage.

The workflow is connected: design decisions affect validation, live cleaning, reconciliation and ultimately lock readiness.

01 / 10

Protocol Review

Quality question
PROTOCOL→eCRF→EDC→UAT→LIVE DATA→RECON→CLEAN→LOCK
Core toolkit

Systems, standards and analysis.

SYSTEMS

Clinical Platforms

Medrio, Medidata Rave, REDCap, Veeva/Flex eTMF, RealTime CTMS and ePRO/eCOA workflows.

STANDARDS

Data Standards

CDISC with CDASH and SDTM familiarity, plus MedDRA and WHO-DD terminology workflows.

AUTOMATION

Technical Toolkit

Python, VBA, SAS 9.4, R, Power BI and Excel for review, reconciliation, QC and operational analytics.